N/A
N=19
Sleep Device Testing to Promote Sleep in Infants
Insomnia Chronic
Bottom Line
View on ClinicalTrials.gov: NCT05078112 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary — -0.88 awakenings per night — p=0.000393
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep sensor technology (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary |
-0.88 | 0.000393 sig |
| SECONDARY Change in BISQ-SF (Brief Infant Sleep Questionnaire - Short Form) Score |
13.4 | — |
| SECONDARY Change in Caregiver Epworth Sleepiness Scale (ESS) |
-0.94 | — |
| SECONDARY Change in Patient Health Questionnaire-2 (PHQ-2) Score |
-0.47 | — |
Summary
Infants often have sleep challenges. Most of these challenges in otherwise healthy children and due to behavioral insomnia. The goal for infants is to become independent sleepers by learning the process of self-soothing. This study hopes to determine if technology based on sensors is able to help teach self-soothing to infants.
Eligibility Criteria
Inclusion Criteria
- Age between 2-12 months.
- Meets clinical criteria for behavioral insomnia of childhood, sleep association subtype, as defined by the International Classification of Sleep Disorders Manual.
Exclusion Criteria
- Diagnosed comorbid health problem that may disrupt sleep.
- History of birth prior to 37 weeks gestational age.
Data sourced from ClinicalTrials.gov (NCT05078112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.